NCT02142725
Terminated
Phase 3
Randomized, Double-blind, Double-dummy, Placebo-controlled, Phase III Clinical Trial on the Efficacy and Safety of a 12-weeks add-on Treatment With LT 02 vs. Placebo in Patients With Ulcerative Colitis Refractory to Standard Treatment With Mesalamine
Overview
- Phase
- Phase 3
- Intervention
- LT-02
- Conditions
- Ulcerative Colitis
- Sponsor
- Dr. Falk Pharma GmbH
- Enrollment
- 468
- Locations
- 1
- Primary Endpoint
- Rate of clinical remission
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to compare two different dosing regimens of phosphatidylcholine versus placebo for the induction of remission in ulcerative colitis patients non-responsive to standard mesalamine treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Established diagnosis of ulcerative colitis
- •Active ulcerative colitis disease extent ≥ 15 cm
- •Active disease despite treatment with mesalamine
Exclusion Criteria
- •Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, microscopic colitis, diverticular disease associated colitis,
- •Toxic megacolon or fulminant colitis
- •Colon resection
- •Evidence of infectious colitis
- •Celiac disease
- •Bleeding hemorrhoids
- •History or presence of ischemic heart disease, myocardial infarction, peripheral arterial disease, ischemic stroke, or transient ischemic attack
- •Any severe concomitant renal, endocrine, or psychiatric disorder
- •Any relevant known systemic disease
- •History of cancer in the last five years
Arms & Interventions
LT-02
LT-02 0.8g four times daily
Intervention: LT-02
B: LT-02
LT-02 1.6g twice daily
Intervention: LT-02
Placebo
LT-02 Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Rate of clinical remission
Time Frame: 12 weeks
Secondary Outcomes
- Number of days with urgency per week(12 weeks)
- Number of stools per week(12 weeks)
- Physician's global assessment at final visit(12 weeks)
- Rate of patients with clinical improvement(12 weeks)
- Time to first resolution of symptoms(12 weeks)
- Rate of mucosal healing(12 weeks)
- Rate of histologic remission(12 weeks)
- Quality of life(12 weeks)
Study Sites (1)
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